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Vacancy Details

IT/Software

Software Quality Engineer - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 19/07/2018
Job Reference: 96758

Job Description

Contact: Karl Lippett
Email: recruit@hero.ie
Telephone: 086 1070950

Software Quality Engineer
Our client, a medical device company in Galway is currently looking to recruit a Software Quality Engineer for their site.

Duties/Responsibilities:
  • Lead Quality and Compliance activities in relation to Software projects.
  • Support, guide, and monitor projects, to ensure that approved software development standards, processes, and procedures are adhered to, as well as make recommendations on the adoption of industry best-practices.
  • Ensure that company processes, SOPs and forms for computer systems control and validation continue to meet the requirements of relevant regulations and are fit for purpose.
  • Collaborate with project teams to set determine the validation strategy and plan for execution.
  • Quality reviewer on all computer systems validation documentation and system supporting documentation.
  • Author computer system validation documentation; test scripts, protocols, reports,
  • Pre and post-execution approval for all validation test scripts
  • Review and approval of deviations arising from computer system validation activities. Provide input into addressing deviations and approval of deviation outcome.

Duties specific to ERP implementation project;
  • Responsible for the accuracy of completeness of static and dynamic data relating to QA/RA functionality.
  • Responsible for determining system parameters & Code Tables relating to QA/RA functionality.
  • Responsible for preparation of specifications, implementation and testing of ERP system-generated documentation related to QA/RA functionality, e.g. labels, forms, reports.
  • Responsible for definition and control of audit logs and electronic signatures.
  • Test and where applicable design and implement enhancements to software system in conjunction with the software vendor to ensure the business needs are met.
  • Author computer system training guides and operating instructions for QA/RA functionality.
  • Work with QA/RA staff to implement changes to business processes and related SOPs to accommodate ERP functionality.
  • Author new SOPs and Work Instructions relating to new ERP functionality.
  • Provide training to QA/RA staff in the use of system functionality.

Specific Requirements
  • Ability to work within a team environment to achieve agreed company goals.
  • Ability to communicate effectively with all levels of the company.
  • Ability to meet deadlines and follow through on assigned deliverables.
  • Attention to detail.
  • Proficiency in use of desktop software applications such as MS Office

Education / Experience
  • BSc. degree in Computer Science or Quality Assurance, or equivalent industrial experience with Computer Software Validation within the medical device industry, of which at least two years must be within a quality assurance or related role.
  • Experience of implementation and validation ERP business systems is desired.
  • Understanding of ISO 13485 and FDA QSR quality standards, particularly 21 CFR Part11 and Part 820.
  • Familiarity with GAMP5 Guideline for ‘Risk-Based approach to GxP Compliant Computerised systems.
  • Familiarity with Agile practices for software implementation and product development, particularly SCRUM.

For further information on this Software Quality Engineer role in Galway please contact Karl Lippett on 086 1070950 / recruit@hero.ie

Check out all our open jobs on our HERO Recruitment website – www.hero.ie
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

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